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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004338-26 | EudraCT Number |
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Poor recruitment due to rare targeted population
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The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.
Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 240 mg/80 mg | Experimental | Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) |
|
| Goserelin (3.6 mg) + bicalutamide (50 mg) | Active Comparator | Goserelin (3.6 mg) + bicalutamide (50 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | After treatment of 12 weeks compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total IPSS at Weeks 4 and 8 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facharztpraxis für Urologie | Bamberg | 96047 | Germany | |||
| Gemeinschaftspraxis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23258223 | Result | Anderson J, Al-Ali G, Wirth M, Gual JB, Gomez Veiga F, Colli E, van der Meulen E, Persson BE. Degarelix versus goserelin (+ antiandrogen flare protection) in the relief of lower urinary tract symptoms secondary to prostate cancer: results from a phase IIIb study (NCT00831233). Urol Int. 2013;90(3):321-8. doi: 10.1159/000345423. Epub 2012 Dec 15. | |
| 34350976 |
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The participants were recruited by outpatient urologists. 280 participants were to be randomised in a 3:1 ratio to one of two treatment groups (210 patients were to be treated with degarelix; 70 patients were to be treated with goserelin plus bicalutamide). The trial was stopped early due to poor recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240 mg/80 mg | Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) |
| FG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin (3.6 mg) + bicalutamide (50 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Goserelin | Drug | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
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| Bicalutamide | Drug | On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin. |
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| After treatment of 4 and 8 weeks compared to Baseline |
| Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec) | After treatment of 4, 8 and 12 weeks compared to Baseline |
| Change From Baseline in Residual Volume (Vresidual) at Each Visit | Uroflowmetry was used to quantify the residual volume (Vresidual; mL) | After treatment of 4, 8 and 12 weeks compared to Baseline |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 | TRUS is a method of measuring the size of the prostate. | After 12 weeks treatment compared to Baseline |
| Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline |
| Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | After treatment of 4, 8 and 12 weeks compared to Baseline |
| Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL. | After treatment of 4, 8 and 12 weeks compared to Baseline |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value. | Baseline to 12 weeks of treatment |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial. | Baseline to 12 weeks of treatment |
| Borken |
| 46325 |
| Germany |
| Gemeinschaftspraxis | Cologne | 50667 | Germany |
| Universitätsklinikum Dresden | Dresden | 01307 | Germany |
| Euromed Clinic | Fürth | 90763 | Germany |
| Urologische Gemeinschaftspraxis | Hamburg | 22399 | Germany |
| VITURO Gesellschaft für Klinische Studien | Leipzig | 04109 | Germany |
| Klinikum Offenbach GmbH | Offenbach | 63069 | Germany |
| Urologische Klinik Planegg | Planegg | 82152 | Germany |
| Wuppertaler Gemeinschaftspraxis | Wuppertal | 42103 | Germany |
| Complejo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Hospital Universitario Principe de Asturias | Alcalá de Henares-Madrid | 28805 | Spain |
| Fundacion Hospital Alcorcón | Alcorcón | 28922 | Spain |
| Fundación Puigvert | Barcelona | 08025 | Spain |
| Hospital de Basurto | Bilbao (Bizkaia) | 48013 | Spain |
| Hospital universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico Universitario S. Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda, Madrid | 28222 | Spain |
| Hospital Manacor | Manacor | 07500 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33006 | Spain |
| Hospital Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Virgen Macarena | Seville | 41014 | Spain |
| Hospital Xeral de Vigo | Vigo | 36204 | Spain |
| United Bristol Healthcare NHSTrust Bristol Royal Infirmary | Bristol | BS2 8HW | United Kingdom |
| Falkirk and District Royal Infirmary | Falkirk | FK1 5QE | United Kingdom |
| Southern General Hospital | Glasgow | G51 4TF | United Kingdom |
| Castle Hill Hospital | Hull | HU16 5JQ | United Kingdom |
| Whipps Cross University Hospital | London | E11 1NR | United Kingdom |
| The Royal Free Hospital | London | NW3 2QG | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Royal Hallamshire Hospital, Sheffield South | Sheffield | S10 2JF | United Kingdom |
| Sunderland Royal Hospital | Sunderland | SR4 7TP | United Kingdom |
| Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. |
| Full Analysis Set (FAS) |
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| Per Protocol (PP) Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240 mg/80 mg | Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) |
| BG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin (3.6 mg) + bicalutamide (50 mg) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Full Analysis Set (FAS). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | FAS. | Count of Participants | Participants |
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| Race (NIH/OMB) | FAS. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | FAS. | Number | participants |
| |||||||||||||||
| Body weight | FAS. | Mean | Standard Deviation | kilogram |
| ||||||||||||||
| Body mass index | FAS. | Mean | Standard Deviation | kilogram per square meter |
| ||||||||||||||
| Gleason Score | FAS. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. | Number | participants |
| |||||||||||||||
| Stage of Prostate Cancer | FAS. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor. The majority of participants did not have their prostate cancer classified for the complete TNM scale (17 participants) or were known for having metastatic prostate cancer (14 participants). | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | score on scale | After treatment of 12 weeks compared to Baseline |
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| Secondary | Change From Baseline in Total IPSS at Weeks 4 and 8 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | FAS, LOCF. | Posted | Mean | Standard Deviation | score on scale | After treatment of 4 and 8 weeks compared to Baseline |
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| Secondary | Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit | Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec) | FAS, LOCF. | Posted | Mean | Standard Deviation | mL/sec | After treatment of 4, 8 and 12 weeks compared to Baseline |
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| Secondary | Change From Baseline in Residual Volume (Vresidual) at Each Visit | Uroflowmetry was used to quantify the residual volume (Vresidual; mL) | FAS, LOCF. | Posted | Mean | Standard Deviation | mL | After treatment of 4, 8 and 12 weeks compared to Baseline |
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| Secondary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 | TRUS is a method of measuring the size of the prostate. | FAS, Observed Cases (OC). | Posted | Mean | Standard Deviation | mL | After 12 weeks treatment compared to Baseline |
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| Secondary | Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit | FAS, OC. | Posted | Number | participants | After treatment of 4, 8 and 12 weeks compared to Baseline |
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| Secondary | Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit | FAS, LOCF. | Posted | Median | Full Range | percentage | After treatment of 4, 8 and 12 weeks compared to Baseline |
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| Secondary | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL. | FAS, OC. | Posted | Mean | Standard Deviation | score on scale | After treatment of 4, 8 and 12 weeks compared to Baseline |
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| Secondary | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value. | FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26). | Posted | Number | participants | Baseline to 12 weeks of treatment |
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| Secondary | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial. | FAS. | Posted | Number | participants | Baseline to 12 weeks of treatment |
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12 weeks.
Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 240 mg/80 mg | Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) | 0 | 27 | 14 | 27 | ||
| EG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin (3.6 mg) + bicalutamide (50 mg) | 1 | 13 | 7 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic failure | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
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| Reproductive tract hypoplasia, male | Congenital, familial and genetic disorders | MedDRA (10.1) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (10.1) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (10.1) | Systematic Assessment |
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| Prostatic obstruction | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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Early termination leading to small numbers of subjects analyzed.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
| D017273 | Goserelin |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Germany |
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| United Kingdom |
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| 5-6 |
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| 7-10 |
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| Locally Advanced |
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| Metastatic |
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| Not Classifiable |
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| Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates. | ANCOVA | The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis. | 0.0398 | PP analysis set. | Mean Difference (Final Values) | -5.88 | 2-Sided | 95 | -11.5 | -0.291 | Yes | Non-Inferiority or Equivalence | The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set. If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used. |
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